GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes

Early Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Glucose-dependent Insulinotropic polypeptide; Other: saline

• Registration Number: NCT01414556
• Lead Sponsor: Mikkel Christensen

Brief Summary

Investigation of GIP effects at fasting and hypoglycemia

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Primary Completion: 2012-07
• Study Completion: 2012-11
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-31
• Last Update Posted: 2013-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion Criteria

• HbA1c >9 %
• Liver disease (ALAT/ASAT >2 x upper normal limit)
• Diabetic nephropathy (s-creatinine >130 µM or albuminuria)
• Proliferative diabetic retinopathy (anamnestic)
• Severe arteriosclerosis or heart failure (NYHA group III og IV)
• Anemia
• treatment with medication not applicable to pause for 12 hours
• Fasting plasma glucose >15 mM on screening day.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
hyperglycemia	saline	-
hyperglycemia	Glucose-dependent Insulinotropic polypeptide	-
fasting glycemia	Glucose-dependent Insulinotropic polypeptide	-
hypoglycemia	saline	-
fasting glycemia	saline	-
hypoglycemia	Glucose-dependent Insulinotropic polypeptide	-

Primary Outcome Measures

Name	Time	Method
glucagon/insulin(c-peptide) absolute, incremental and area under curve values	approx. 15 minutes intervals, time 0 to 120 min

Secondary Outcome Measures

Name	Time	Method
plasma gut hormones and nutrients	approx. 15 minutes intervals, time 0 to 120 min

Trial Locations

Locations (1)

Gentofte Hospital; 🇩🇰 Hellerup, Denmark